Medical Writer

Position Overview

The role of Medical Writer at PTF Consulting, LLC is designed for an experienced professional focused on the planning, development, and execution of complex medical writing projects that align with regulatory submissions for both U.S. and international markets. This position plays a crucial role in collaborating with cross-functional teams including Regulatory Affairs, Quality, Clinical Project Management, Biostatistics, and Data Management. The Medical Writer not only leads project execution but also provides strategic and technical leadership to ensure high-quality and compliant documentation.

Key Responsibilities

The key responsibilities for the Medical Writer position include:

• Lead and manage complex medical writing projects while ensuring timely delivery and adherence to quality standards.

• Collaborate cross-functionally with various teams to ensure project success and alignment.

• Serve as a subject matter expert on medical writing standards and regulatory requirements, actively participating in process improvement initiatives, including MDR compliance.

• Mentor and guide team members, offering coaching and fostering knowledge transfer to enhance professional growth.

• Represent the medical writing function in core team meetings, assisting with the development of reporting plans and facilitating global regulatory submissions.

• Drive process innovation by identifying and implementing continuous improvements in medical writing practices and tools.

• Author, review, and edit key regulatory and clinical documents, ensuring clarity, consistency, and compliance with applicable guidance.

• Participate in strategic planning for document development, establishing review cycles, and ensuring submission readiness.

Required Qualifications

To be considered for this position, candidates should possess:

• A Bachelor's degree in a related scientific or technical field, paired with 8+ years of relevant experience, or an advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) combined with 6+ years of relevant scientific experience.

Preferred Qualifications

Candidates with the following qualifications will be prioritized:

• Previous experience as a medical writer in a medical device company, especially with cardiovascular devices.

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• Proven success in authoring and managing various regulatory documents, including:

  • EU Clinical Evaluation Plans and Reports (CEP, CER) per MDR and MEDDEV standards.
  • Post-Market Clinical Follow-up Plans and Reports.
  • Summary of Safety and Clinical Performance (SSCP).
  • Additional regulatory and clinical documentation as needed.

• High proficiency in conducting medical literature research (i.e., through PubMed, Medline) and synthesizing scientific data.

• Strong ability to engage cross-functional teams, discussing and interpreting complex technical topics effectively.

• Demonstrated leadership capabilities including coaching, mentoring, and developing competencies within the medical writing team.

• Advanced skills in Microsoft Office, EndNote, and various database tools (such as Medline, PubMed).

• Exceptional editing, writing, and communication skills, with a keen attention to detail.

• Strong project management skills, capable of prioritizing multiple deliverables in a fast-paced environment.

• Familiarity with biomedical statistics and clinical study documentation standards.

• Ability to influence and collaborate across various organizational levels, effectively managing stakeholder expectations.

Why Join Us

Choosing to join PTF Consulting, LLC provides a chance to directly impact patient outcomes by supporting important innovations in cardiac surgery. The company fosters an environment where collaboration thrives among industry-leading experts and encourages integrity, innovation, and teamwork as core values. Additionally, employees enjoy flexible work arrangements, including onsite, hybrid, or fully remote options.

Equal Employment Opportunity (EEO) Statement: PTF Consulting, LLC prides itself on being an Equal Opportunity Employer. The organization celebrates diversity and is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without any differentiation based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, marital status, protected veteran status, or any other characteristic protected by applicable law.

This job offer was originally published on remotive.com